CLASS II ONGOING Drug recall · Reported 24 Jul 2024 · FDA Enforcement Report

Pravastatin Sodium Tablets, USP 80mg recalled

Glenmark Pharmaceuticals Inc., USA is recalling Pravastatin Sodium Tablets, USP 80mg, distributed nationwide in the US. The recall was initiated on 28 Jun 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot#: a) 17211249, 17211264, 17211266,17211286, Exp 6/30/24; 17211525, 17211535, 17211549, Exp 7/31/24; 17211787, 17211801, 8/31/24; 17212041, 9/30/24; 17212088, 17212106, Exp 10/31/24; 17212346, 17212345, 11/30/24; 17220053, 17220054, 17220055 12/31/24; 17220309, 17220310, Exp 1/31/25; b) 17211290, 6/30/2024

NDC68462-195, 68462-196, 68462-197, 68462-198

UPC0368462195901, 0368462198902

Quantity recalleda) 145,800 bottles; b) 1,368 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0612-2024
FDA event ID: 94899
Recalling firm: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Brand: Pravastatin Sodium
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Classification: Class II
Status: Ongoing
Recall initiated: 28 Jun 2024
FDA classified: 18 Jul 2024
Reported: 24 Jul 2024
Type: Voluntary: Firm initiated
Reason category: Potency & Assay
Drug class: Cholesterol Medication

Timeline

28 Jun 2024	Recall initiated by company
18 Jul 2024	Classified by FDA	+20 days
24 Jul 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Dissolution Specifications: results below specifications

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,

Where it was distributed

USA Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications: results below specifications

Which lots are affected?

Lot#: a) 17211249, 17211264, 17211266,17211286, Exp 6/30/24; 17211525, 17211535, 17211549, Exp 7/31/24; 17211787, 17211801, 8/31/24; 17212041, 9/30/24; 17212088, 17212106, Exp 10/31/24; 17212346, 17212345, 11/30/24; 17220053, 17220054, 17220055 12/31/24; 17220309, 17220310, Exp 1/31/25; b) 17211290, 6/30/2024

Where was it sold?

USA Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Glenmark Pharmaceuticals Inc., USA

All 141

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5 Aug 2026Drug	CLASS II	Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
24 Jun 2026Drug	CLASS II	Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
7 Jan 2026Drug	CLASS II	Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
17 Dec 2025Drug	CLASS III	Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide
10 Dec 2025Drug	CLASS III	Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide

Other Pravastatin recalls

All 17

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets 80mg recalled by Glenmark PharmaceuticalsPravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets, USP, 20mg, a) recalled	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets, 20mg, a) recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets, USP, 80mg, a) recalled	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Pravastatin Sodium Tablets, USP, 20 mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide